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COMPLETED
NCT07809282
PHASE2

A Study of Mitragynine Formulations for Exercise-Induced Muscle Soreness in Healthy Adults

Sponsor: Traditional Naturals Research Inc.

View on ClinicalTrials.gov

Summary

This Phase II randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and physical dependence potential of mitragynine-containing formulations after 28 days of use and assess their effects on exercise-induced muscle soreness in healthy adults. One hundred participants will be randomized in a 1:1:1:1 ratio to SpecioTea 20 mg, SpecioTea 40 mg, MitraPlex 20 mg, or placebo. Participants will complete an exercise challenge to induce delayed-onset muscle soreness (DOMS), undergo efficacy assessments at 24 and 48 hours post-exercise, and continue daily dosing for approximately 28 days followed by withdrawal and safety assessments.

Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Tolerability of Product Formulations Containing Mitragynine and Their Relative Effects on Exercise-induced Muscle Soreness in Healthy Adult Participants.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-02-05

Completion Date

2025-10-22

Last Updated

2026-09-09

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

SpecioTea

SpecioTea is a dried aqueous kratom leaf extract administered orally in capsule form. Participants receive 4 capsules once daily. The study evaluates two dosage levels: 20 mg mitragynine daily (2 active capsules plus 2 placebo capsules) and 40 mg mitragynine daily (4 active capsules).

DIETARY_SUPPLEMENT

MitraPlex

MitraPlex is a dried ethanolic/water kratom leaf extract administered orally in capsule form. Participants receive 4 active capsules once daily providing a total daily dose of 20 mg mitragynine.

OTHER

Placebo

Matching placebo capsules administered orally. Participants receive 4 placebo capsules once daily. Placebo capsules are visually indistinguishable from active study product capsules to maintain blinding.

Locations (1)

Apex Trials

Guelph, Ontario - on, Canada